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The Effects of a Tourniquet in Total Knee Arthroplasty.

Primary Purpose

Osteoarthritis, Knee

Status
Active
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Tourniquet
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Arthroplasty, Replacement, Knee, Tourniquets, Pain, postoperative, Muscle strength

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Knee osteoarthrosis qualifying for total knee arthroplasty

Exclusion Criteria:

  • Coagulation disease
  • Rheumatoid arthritis
  • Peripheral vascular disease
  • Malign disease
  • Pregnancy
  • On-going infection
  • Not able to understand written and oral information in Norwegian

Sites / Locations

  • Orthopaedic department, Trondheim University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

No tourniquet

Tourniquet

Arm Description

No use of tourniquet during surgery

Use of tourniquet during surgery. The cuff will be inflated to 300mmHg

Outcomes

Primary Outcome Measures

Mmax
EMG recordings are made using 10mm electrodes (Ag-AgCl) attached in a bipolar configuration over the vastus lateralis and rectus femoris
Nerve growth factor (NGF)
Analysis from muscle biopsies harvested from the m. vastus lateralis
Forgotten Joint Score
The stair climbing test measures the time (in seconds) to ascend, turn around and descend a regular stairway of 11 steps. The patients are asked to perform the test as quickly as possible.

Secondary Outcome Measures

Maximal leg strength
1RM leg strength is measured using a leg press ergometer with the participant in a supine position (Steens Physical; Ring Mekanikk, Moelv, Norway)
Maximal knee extension strength
1RM knee extension is measured using a knee extension equipment (Body-Solid, Forest Park, IL, USA) with the participant in a seated position.
Rate of force development, voluntary activation and muscle contractility
Daily physical activity
Body worn activity monitor
EuroQual 5D-L
Patient reported outcome measure
Numeric Rating Scale (NRS)
Evaluating pain. The scale range from 0 (no pain) to 10 (worst pain imaginable) (7). The patients are asked to write down NRS values both at rest and during activity each day for the first 4 weeks postoperatively in a home log.
Hemoglobin values
g/dL
Volume of bleeding
Total volume of bleeding during surgery and in the drain
Length of hospital stay
Number of days
Knee circumference
The circumference of the knee is measured 1 cm proximal to the patella base
Knee joint range of motion
Maximal flexion and extension
Forgotten Joint Score
Patient reported outcome measure
Gene expression analyses. RT-PCR for expression levels for VEGF, NGF, SP, CGRP, IL-6, IL-1, TNF-alpha, Bad, Bax, Bid, Bim, Fas, Fas-ligand, Bcl-2, Mcl, and FLIP. Results will be normalized to GAPDH expression levels.
Analysis from muscle biopsies harvested from the vastus lateralis (muscle)
Neuronal markers; PGP, GAP-43
Analysis from muscle biopsies harvested from the vastus lateralis (muscle)
Neuromediators; SP, CGRP, glutamate
Analysis from muscle biopsies harvested from the vastus lateralis (muscle)
Pain receptors; glutamate receptors
Analysis from muscle biopsies harvested from the vastus lateralis (muscle)

Full Information

First Posted
August 30, 2018
Last Updated
April 28, 2022
Sponsor
Norwegian University of Science and Technology
Collaborators
Zimmer Biomet, University of British Columbia, Karolinska University Hospital, St Olavs Hospital University Hospital in Trondheim, Kristiansund Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03666598
Brief Title
The Effects of a Tourniquet in Total Knee Arthroplasty.
Official Title
The Effects of a Tourniquet on Implant Migration and Muscle Strength and Function in Patients Operated With Total Knee Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 28, 2019 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
Zimmer Biomet, University of British Columbia, Karolinska University Hospital, St Olavs Hospital University Hospital in Trondheim, Kristiansund Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
About 5000 total knee arthroplasties (TKA) are performed annually in Norway. Pain and reduced physical function is present in patients operated with TKA up to a year after surgery and about one of five patients are not satisfied with the outcome from TKA surgery. The use of tourniquet during surgery may also have impact on pain and physical function. Whether TKA surgery should be performed with or without the use of tourniquet, is a much-debated issue in orthopedic surgery today, and there is still no consensus in this field. This study will investigate early muscle strength and power recovery, neuromuscular recordings, neuronal changes and patient reported outcome measures after surgery with tourniquet versus not tourniquet.The findings in this study are expected to have implications for rehabilitation and the outcome of the TKA surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
Arthroplasty, Replacement, Knee, Tourniquets, Pain, postoperative, Muscle strength

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No tourniquet
Arm Type
No Intervention
Arm Description
No use of tourniquet during surgery
Arm Title
Tourniquet
Arm Type
Experimental
Arm Description
Use of tourniquet during surgery. The cuff will be inflated to 300mmHg
Intervention Type
Device
Intervention Name(s)
Tourniquet
Intervention Description
In the patients randomized to the use of tourniquet, the tourniquet time starts before skin incision and terminates when the wound closure starts. The cuff pressure is set at 300mmHg.
Primary Outcome Measure Information:
Title
Mmax
Description
EMG recordings are made using 10mm electrodes (Ag-AgCl) attached in a bipolar configuration over the vastus lateralis and rectus femoris
Time Frame
Change from 1) preoperative (baseline) to day 2 postoperative, 2) change from preoperative to 8 weeks postoperative, 3) change from preoperative to 1 year postoperative
Title
Nerve growth factor (NGF)
Description
Analysis from muscle biopsies harvested from the m. vastus lateralis
Time Frame
Change from during surgery to 8 weeks postoperative
Title
Forgotten Joint Score
Description
The stair climbing test measures the time (in seconds) to ascend, turn around and descend a regular stairway of 11 steps. The patients are asked to perform the test as quickly as possible.
Time Frame
Change from 1) preoperative (baseline) to 2) change from preoperative to 8 weeks postoperative, 3) change from preoperative to 1 year postoperative
Secondary Outcome Measure Information:
Title
Maximal leg strength
Description
1RM leg strength is measured using a leg press ergometer with the participant in a supine position (Steens Physical; Ring Mekanikk, Moelv, Norway)
Time Frame
Change from 1) preoperative (baseline) to day 2 postoperative, 2) change from preoperative to 8 weeks postoperative, 3) change from preoperative to 1 year postoperative
Title
Maximal knee extension strength
Description
1RM knee extension is measured using a knee extension equipment (Body-Solid, Forest Park, IL, USA) with the participant in a seated position.
Time Frame
Change from 1) preoperative (baseline) to day 2 postoperative, 2) change from preoperative to 8 weeks postoperative, 3) change from preoperative to 1 year postoperative
Title
Rate of force development, voluntary activation and muscle contractility
Time Frame
Change from 1) preoperative (baseline) to day 2 postoperative, 2) change from preoperative to 8 weeks postoperative, 3) change from preoperative to 1 year postoperative
Title
Daily physical activity
Description
Body worn activity monitor
Time Frame
Change from day 3 - 10 postoperative to 1 year postoperative (1 week measurement)
Title
EuroQual 5D-L
Description
Patient reported outcome measure
Time Frame
Preoperative, 8 weeks, 1 year postoperative
Title
Numeric Rating Scale (NRS)
Description
Evaluating pain. The scale range from 0 (no pain) to 10 (worst pain imaginable) (7). The patients are asked to write down NRS values both at rest and during activity each day for the first 4 weeks postoperatively in a home log.
Time Frame
Preoperative, from day 1 postoperative to 4 weeks postoperative, 8 weeks and 1 years postoperative
Title
Hemoglobin values
Description
g/dL
Time Frame
Preoperatively, day 1 postoperative
Title
Volume of bleeding
Description
Total volume of bleeding during surgery and in the drain
Time Frame
During surgery and day 1 postoperative
Title
Length of hospital stay
Description
Number of days
Time Frame
From day of surgery until 10 days postoperative
Title
Knee circumference
Description
The circumference of the knee is measured 1 cm proximal to the patella base
Time Frame
Preoperative and day 1 postoperative
Title
Knee joint range of motion
Description
Maximal flexion and extension
Time Frame
Preoperative, 1 day, 8 weeks,1 year postoperative
Title
Forgotten Joint Score
Description
Patient reported outcome measure
Time Frame
Preoperative, 8 weeks, 1 year postoperative
Title
Gene expression analyses. RT-PCR for expression levels for VEGF, NGF, SP, CGRP, IL-6, IL-1, TNF-alpha, Bad, Bax, Bid, Bim, Fas, Fas-ligand, Bcl-2, Mcl, and FLIP. Results will be normalized to GAPDH expression levels.
Description
Analysis from muscle biopsies harvested from the vastus lateralis (muscle)
Time Frame
Peroperative and 8 weeks postoperative
Title
Neuronal markers; PGP, GAP-43
Description
Analysis from muscle biopsies harvested from the vastus lateralis (muscle)
Time Frame
During surgery and 8 weeks postoperative
Title
Neuromediators; SP, CGRP, glutamate
Description
Analysis from muscle biopsies harvested from the vastus lateralis (muscle)
Time Frame
During surgery and 8 weeks postoperative
Title
Pain receptors; glutamate receptors
Description
Analysis from muscle biopsies harvested from the vastus lateralis (muscle)
Time Frame
During surgery and 8 weeks postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Knee osteoarthrosis qualifying for total knee arthroplasty Exclusion Criteria: Coagulation disease Rheumatoid arthritis Peripheral vascular disease Malign disease Pregnancy On-going infection Not able to understand written and oral information in Norwegian
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Siri Forsmo, prof
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Study Director
Facility Information:
Facility Name
Orthopaedic department, Trondheim University Hospital
City
Trondheim
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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The Effects of a Tourniquet in Total Knee Arthroplasty.

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